Lindor 1997.

Methods	Study design: a multicenter, randomised, double‐blind, placebo‐controlled trial.
Participants	Country: United States of America . Publication language: English. Inclusion criteria ‐ a chronic cholestatic liver disease of at least six months duration; ‐ a serum ALP level at least 1.5 times the upper normal limit; ‐ retrograde, operative, or percutaneous cholangiographic findings of intrahepatic or extrahepatic biliary‐duct obstruction, beading, or narrowing consistent with primary sclerosing cholangitis; ‐ a liver biopsy in the previous three months with compatible findings. Exclusion criteria (1) treatment with UDCA, colchicine, corticosteroids, cyclosporine, methotrexate, or penicillamine in the preceding three months; (2) anticipated need for liver transplantation within one year on the basis of the Mayo survival model; (3) recurrent variceal haemorrhage, spontaneous uncontrolled encephalopathy, or ascites resistant to diuretic agents; (4) pregnancy; (5) an age of less than 18 years or more than 70 years; (6) features suggestive of coexisting liver diseases, including primary biliary cirrhosis, chronic alcoholic liver disease, autoimmune hepatitis, chronic hepatitis B or C, or cholangiocarcinoma; (7) a history of intraductal stones or biliary tract operations apart from cholecystectomy; (8) recurrent ascending cholangitis requiring hospitalisation more than twice a year. Participants (1) UDCA group (n = 53) Mean age (years +/‐ standard deviation): 41.7 +/‐ 1.8; Ratio of sex (M/F): 32/21; Concurrent IBD no. : 41 (77%). (2) Placebo group (n = 52) Mean age (years +/‐ standard deviation): 43.8 +/‐ 1.6; Ratio of sex (M/F): 29/23; Concurrent IBD no. : 44 (85%).
Interventions	UDCA group: Dose: 13 to 15 mg/kg body weight/day in four divided doses. Route: orally. Duration: two years. Placebo group: identical‐appearing capsules administered in the same quantity and manner.
Outcomes	Number of treatment failure (withdrawal from study, liver transplantation, worsening of symptoms, varices, ascites, encephalopathy, histologic progression, and death) at the end of treatment; Serum bilirubin, ALP, AST, and albumin level at the end of treatment; and adverse events.
Notes	Letter was sent to the authors in August 2010. A reply with no additional information was received shortly after.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	Computer‐generated, blocked randomisation.
Allocation concealment?	Unclear risk	Method of allocation concealment not described.
Blinding? All outcomes	Low risk	Placebo was given in identical tablets and in the same way as the interventional drug, and patients, physicians, nurses and study coordinators were blinded to the administration of both.
Incomplete outcome data addressed?	High risk	The number and reasons for withdrawal of patients were not stated in the report, although a table shows a withdrawal of 13 patients from the UDCA‐group and 9 patients from the control group with no explanations given. Median follow‐up time was 2.2 years.
Free of selective reporting?	Unclear risk	Not enough information provided. Study outcomes are not clearly stated and all data are not shown.
Sample size calculation	Low risk	Stated and used.
Intention‐to‐treat analysis	High risk	Stated but not used.